Not Applicable.
Not Applicable.
The present invention generally relates to an oral contraceptive delivery system, and in particular an oral contraceptive delivery system involving novel alternate dose forms to improve compliance.
The efficacy of oral contraceptives tends to be particularly patient compliance dependent, largely due to the lack of a disease state or symptoms to remind a human female patient (sometimes referred to simply as xe2x80x9cpatientxe2x80x9d or xe2x80x9cwomanxe2x80x9d) to take a pill. The single most significant reason for failure with oral contraceptives is use, rather than method, failure. That is, unless the contraceptives are used according to the prescribed regimen, the contraceptives can fail to effectively help a patient avoid pregnancy. Further, in order to be most effective in preventing pregnancy and maintaining menstrual cycle control, proper compliance with an oral contraceptive dosage regimen requires that the oral contraceptives be taken at about the same time each day.
Various attempts have been made to improve patient compliance with contraceptive regimens. For example, it has been suggested that progestin rods can be inserted subdermally. This procedure has been described, for example, in U.S. Pat. No. 5,756,115. This technique has the significant disadvantage of requiring a surgical incision, a procedure that is highly disfavored by a relatively large segment of the patient population.
As another example, it has been suggested that DEPO-PROVERA(copyright) (Pharmacia, Inc.) medroxyprogesterone acetate can be injected subcutaneously every three months. This technique has been described, for example, in U.S. Pat. No. 4,639,439. This procedure has the disadvantage of requiring an injection via hypodermic needle, which is also a procedure that is disfavored by many patients.
In many cases, the patient prefers to carry the contraceptive pills on her person as a matter of lifestyle or personal discretion. This is especially true for younger patients, and it is not uncommon for such patients to exchange pills. Members of this population tend to view portable packaging of the pills, immediate access to the pills, and ease of pill use as significant benefits.
Prior proposed solutions to the compliance problem have tended to focus primarily or exclusively on optimizing compliance packaging, rather than on changes to the dosage form. It has been suggested that instead of being packaged in vials, contraceptive pills can be packaged in 21 or 28 day blister packages. It has also been suggested that the size of these packages can be reduced to improve portability and confidentiality.
Although oral contraceptive pills provided in a small blister package are somewhat more convenient to carry and to conceal, they are not necessarily easy to ingest. Access to water to facilitate contraceptive pill taking remains a problem. Most medications are typically stored in a medicine cabinet and therefore are likely to be near a water source. On the contrary, oral contraceptive pills are often carried on the person and a source of water is not always available when it is time to take the oral contraceptive pill. Additionally, a certain segment of the patient population will have trouble swallowing pills, irrespective of access to water.
The present invention provides an improved oral contraceptive tablet. The technology encompassed in the invention involves a chewable, palatable oral contraceptive tablet that has appropriate size and hardness for blister packaging and compliant use.
One aspect of the present invention relates to a chewable, palatable oral contraceptive tablet, comprising an oral contraceptive agent, a chewable carrier suitable for human consumption, and not comprising a ferrocene compound.
Another aspect of this invention relates to a method of human female oral contraception, the method comprising providing a chewable, palatable oral contraceptive tablet comprising a contraceptively effective amount of an oral contraceptive agent, and a chewable carrier suitable for human consumption, and not comprising a ferrocene compound, and administering the tablet to a human female.
Yet another aspect of this invention relates to a method of enhancing compliance with a human female oral contraceptive regimen involving oral contraceptive tablets, the method comprising providing chewable, palatable oral contraceptive tablets comprising a contraceptively effective amount of an oral contraceptive agent, and a chewable carrier suitable for human consumption, and not comprising a ferrocene compound, and administering the tablets to the human female in accordance with the contraceptive regimen.
Not Applicable.